Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis, Skin Diseases

In brief

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

Key facts

Study ID

NCT05469464

Run by

UNION therapeutics

People needed

235

Starts

2022-07-11

Expected to finish

2024-02-15

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of giving signed informed consent.
• Male and female patients ≥18 years of age
• Body weight of >40 kg
• Diagnosis of AD for a minimum of 1 year (before the Screening visit) using the Hanifin and Rajka criteria
• Moderate to severe AD (affected BSA at least 10%, IGA-AD grade of at least 3, and EASI score of at least 16) at the screening and baseline visits
• Candidate for systemic treatment or phototherapy for AD

You may not qualify if…

• Therapy-resistant atopic dermatitis
• Unstable AD with acute deterioration, requiring rescue therapy for AD within 4 weeks of the Screening visit or expected to require rescue therapy within 2 weeks after randomization
• History of allergy or hypersensitivity to any component of the study treatment
• Active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit
• Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma

Where it is running

• Hope Clinical Research — Canoga Park, California, United States
• First OC Dermatology Research Inc — Fountain Valley, California, United States
• Axon Clinical Research — Inglewood, California, United States
• LA Universal Research Center, INC. — Los Angeles, California, United States
• Acclaim Clinical Research Inc. — San Diego, California, United States
• Advance Medical Research Center — Miami, Florida, United States
• Clinical Research Trials of Florida ,Inc. — Tampa, Florida, United States
• Alliance Clinical Research of Tampa — Tampa, Florida, United States
• ALLCUTIS Research, LLC — Beverly, Massachusetts, United States
• Revival Research Institute, LLC — Troy, Michigan, United States
• Michigan Dermatology Institute — Waterford, Michigan, United States
• Excel Clinical Research — Las Vegas, Nevada, United States
• ALLCUTIS Research, LLC — Portsmouth, New Hampshire, United States
• Juva Skin & Laser Center — New York, New York, United States
• Sadick Research Group LLC — New York, New York, United States
• Apex Clinical Research Center — Mayfield Heights, Ohio, United States
• Clinical Trial Network — Houston, Texas, United States
• Tranquility Research — Webster, Texas, United States
• Hautarztpraxis Dr.Gerlach — Dresden, Saxony, Germany
• MVZ DermaKiel GmbH — Kiel, Schleswig-Holstein, Germany
• Fachklinik Bad Bentheim — Bad Bentheim, Germany
• ISA - Interdisciplinary Study Association GmbH — Berlin, Germany
• Rosenpark Research GmbH — Darmstadt, Germany
• TFS Trial From Support GmbH — Hamburg, Germany
• Studienzentrum Dr.Beate Schwarz — Langenau, Germany

Full record on ClinicalTrials.gov

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